Senior Quality Assurance Associate

Role Objectives

The Senior Quality Assurance (QA) Associate plays a critical role within the Quality team, ensuring that pharmaceutical distribution and manufacturing activities are conducted in compliance with applicable regulatory standards (e.g., UK/EU/FDA GMP, GDP, and national health authority requirements).

What You'll Do

• Ensure GMP and GDP compliance across all regulated activities, maintaining best practices at all times.
• Prioritize and oversee compliance activities related to Wholesaler and Manufacturing Licenses/Authorizations in line with regulatory expectations.
• Manage key quality processes, driving operational compliance and identifying risks to patient safety, product quality, or regulatory adherence with effective mitigation strategies.
• Monitor, trend, and analyze quality incidents and metrics, proposing improvements to prevent recurrence and support management review.
• Lead and coordinate investigations for deviations, non-conformances, and complaints, ensuring robust root cause analysis and effective CAPA implementation.
• Initiate and support risk assessments, validation protocols, periodic reviews, and other quality system activities, including post-effectiveness checks for CAPAs and Change Controls.
• Drive timely completion and closure of critical quality records, ensuring appropriate supporting evidence is in place.
• Lead and support change controls, assessing impacts and risks and implementing necessary mitigating actions.
• Cook up and coordinate product recalls and mock recalls as required.
• Create, maintain, review, and archive GxP documentation, ensuring controlled document updates and effective document lifecycle management.
• Develop and execute validation and qualification strategies for shippers, equipment, facilities, IT systems, and warehouse operations, ensuring GMDP compliance.
• Support product disposition from quarantine, perform batch reviews, line clearances, quality inspections, label reviews, and secondary packaging oversight in accordance with SOPs.
• Support batch certification activities, including completion of Product Specification Files and escalation of quality issues to the Qualified Person as needed.
• Provide quality oversight and support for commercial, clinical trial, and supply chain projects, including client calls, technical agreements, audits, and regulatory inspections.
• Contribute to internal and external audits, supplier and vendor qualification, training, and continuous process improvements while promoting collaboration across the global Quality team and wider business.

What You'll Need

• Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
• 2-5 years of experience in a Quality-related role within a regulated environment
• Practical experience in GxP Supply Chain, Production, and Quality Assurance, with knowledge of GMP, GDP, and the supply of unlicensed medicines (including distribution supply chains and unlicensed pathways preferred)
• Strong understanding of core Quality Management System processes, including risk assessments, deviations, change control, and supplier/customer management
• Proven ability to work cross-functionally on new processes, investigations, root cause analysis, and continuous improvement initiatives
• Strong critical thinking and analytical skills, particularly in conducting and reviewing investigations
• Excellent organizational, planning, time management, and administrative skills, with high attention to detail and accuracy under strict deadlines
• Effective verbal and written communication skills, with the ability to manage stakeholders, drive projects independently, and communicate business needs with minimal supervision
• Highly self-motivated, adaptable, solutions-oriented, and able to work independently under pressure, with strong interpersonal skills and proficiency in Microsoft Office, particularly Excel

What We Offer

• Medical, dental, and vision insurance
• FSA, HSA
• Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance
• Group short-term and long-term disability insurance
• Group Life Insurance
• 401K safe harbor plan and company match
• Paid vacation, holiday, sick and volunteer time
• Paid maternity & paternity leave

How We Work at WEP Clinical

We look for individuals who are conscientious, exercise sound judgment, and engage with others thoughtfully and professionally. We believe excellence is achieved through integrity, accountability, and respect for diverse perspectives - and we are committed to helping our people grow and succeed in an inclusive, supportive environment.

Our Services

• Access Programs
• Clinical Trial Services
• Patient Site Solutions
• Clinical Trial Supply
• Market Access and Commercialization

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